Welcome to INTERMACSTM!
The Interagency Registry for Mechanically Assisted Circulatory Support is a North American registry established in 2005 for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. INTERMACSTM was established as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives in conjunction with Dr. James K. Kirklin and the University of Alabama at Birmingham.
INTERMACSTM is a prospective registry that collects clinical data, including follow up, essentially as it happens. Post implant follow up data is collected at 1 week, 1 month, 3 months, 6 months and every 6 months thereafter. Major outcomes after implant, e.g. death, explant, rehospitalization and adverse events, are entered as they occur and also as part of the defined follow-up scheduled intervals.
INTERMACSTM provides contemporary data to demonstrate the continued progress of outcomes, with additional insight into appropriate risk stratification and patient selection. Death, transplant, and explant are the major discrete endpoints recorded.
Complex endpoints that include the patient’s level of function and quality of life, critical to the evaluation of current MCSD therapy, for which improvements in both survival and function have been compelling. These indices are becoming increasingly important as the survival improves, and new devices will be compared for outcomes beyond survival.
The INTERMACS Executive Committee has reviewed the CMS Decision Memo for Ventricular Assists Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R). We are excited to share with you the Executive Committee’s comments.
INTERMACS Comments Regarding the CMS Decision Memo
INTERMACS Reports for CMS
At the request of CMS, INTERMACS has produced two customized reports which are now available to the public.
INTERMACS is pleased to announce the inclusion of the 10,000th ventricular assist device (VAD) in the registry on June 18, 2013.
Sponsored by The National Heart, Lung and Blood Institute (NHLI) and housed at the University of Alabama at Birmingham, INTERMACS launched June 2006 with 15 participating hospitals within the United States. The registry has quickly grown to include the majority of VAD centers in the U.S, is recognized as the Centers for Medicare and Medicaid Services (CMS) mandated registry for all U.S. centers implanting VADS for destination therapy and now has expanded to include all interested North American hospitals.
Currently 150 centers participate in INTERMACS.
The following INTERMACS centers were recognized at the Seventh Annual INTERMACS Meeting on April 5, 2013 as INTERMACS Vanguard Centers. In order to be a Vanguard Center, each site must be a member of INTERMACS for at least one year, maintain regulatory compliance of 100%, maintain data entry compliance of at least 95%, and meet minimum enrollment of 20 participants. Congratulations to these outstanding centers!
This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract Number HHSN268201100025C.